Lethal Indian Cough Syrup Highlights Risk of U.S. Dependence on India for Generic Drugs

Health experts say 69 deaths were "sadly predictable"


WASHINGTON — Americans for Safe Drugs (AFSD) today released a statement after toxic cough syrup from Indian drug firm, Maiden Pharmaceuticals Ltd., killed 69 children in Gambia due to “unacceptable amounts” of contaminating diethylene glycol and ethylene glycol, the World Health Organization analysis concurred. AFSD has repeatedly warned about the risks of importing medicines from Indian firms that have demonstrated a repeated pattern of violating safety regulations.


As Bloomberg reported, India’s “multiple medical scandals” and “patchy quality of domestic inspections and the entrenched culture of jugaad — creative improvisation or bending the rules” demonstrate that importing pharmaceuticals from India poses serious safety risks. Incredibly, investment documents from India highlight how this mentality has helped to cut costs by 33% compared to Western manufacturers — a practice that Bloomberg warns “can have dangerous consequences.” Additionally, “the return of US Food and Drug Administration (FDA) inspectors to Indian factories has revealed a fresh batch of potentially dangerous production defects at plants exporting to American patients.”


“This tragic example highlights the serious risks to Americans, and patients all around the world, for continuing to rely on unsafe drugs from India’s pharmaceutical industry, which has demonstrated a culture of repeatedly violating safety regulations and cutting costs,” said Rosemary Gibson, author of China Rx and Chairwoman of the CPA Healthcare Committee. “It is time for lawmakers and regulators in the U.S. to acknowledge this risk and address it by holding foreign drug makers accountable and enacting policies to reshore the domestic pharmaceutical industry.”


Americans for Safe Drugs is increasingly concerned about the FDA’s continued failure to adequately protect the American public from bad-actor foreign generic pharmaceutical manufacturers that are repeatedly violating FDA’s safety regulations and that have consistently demonstrated a flawed manufacturing process that is jeopardizing the health and safety of tens of millions of patients.


Aurobindo Pharma Limited is a multinational pharmaceutical manufacturing company headquartered in Hyderabad, India, and it is the largest supplier of generic prescriptions in the U.S. In the last five years alone, Aurobindo has had over 15 recalls for hair, mold, and glass found in their products.


This January, the FDA issued a Warning Letter to Aurobindo for “significant deviations from current good manufacturing practices (CGMP) for active pharmaceutical ingredients.” That same month, Auromedics Pharma LLC, a subsidiary of Aurobindo, recalled an injectable antibiotic after a hair was found in a vial.


According to FDA data, Aurobindo has had 14 recalls in the past two years, and they have received multiple Warning Letters. Despite these repeated violations of FDA’s regulations and more than a dozen recent recalls of defective or potentially harmful products, the FDA granted Aurobindo’s subsidiary, Eugia Pharma Specialties Ltd, final approval to manufacture and market its generic version of Bortezomib for an injection used to treat certain types of cancer.


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We are a group of doctors, patients, health care industry experts, and advocates fighting to ensure all generic medicines are safe, affordable, and always available. Unsafe generic drugs from foreign manufacturers in China and India have been sold in the U.S that have been contaminated with carcinogens and fake ingredients, fall apart when tested, and don’t work as they should. We are fighting back to ensure all generic medicines are safe, affordable, and always available. We want every American to be able to trust the generics they take—every pill, every vial, every time.